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ESCO: European Serrated Adenoma Classification Score

Sponsor
Technische Universität München (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03486418
Collaborator
(none)
250
Enrollment
1
Location
36
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.

In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
    Actual Study Start Date :
    Apr 1, 2018
    Actual Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Optical diagnosis of each colorectal polyp [Participants will be followed for the duration of the study an expected average of 6 month]

      The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after;

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • indication for colonoscopy

    • patients >= 18 years

    Exclusion Criteria:

    • pregnant women

    • indication for colonoscopy: inflammatory bowel disease

    • indication for colonoscopy: polyposis syndrome

    • indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

    • contraindication for polyp resection e.g. patients on warfarin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum rechts der Isar der TU München Munich Bayern Germany 81675

    Sponsors and Collaborators

    • Technische Universität München

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Technische Universität München
    ClinicalTrials.gov Identifier:
    NCT03486418
    Other Study ID Numbers:
    • ESCO
    First Posted:
    Apr 3, 2018
    Last Update Posted:
    Sep 18, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenoma
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Sep 18, 2020